Changeflow GovPing Healthcare B.E. Meyers & Co. Variance Application - CDRH
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B.E. Meyers & Co. Variance Application - CDRH

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Summary

B.E. Meyers & Co., Inc. has submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH). The application requests permission to deviate from specific regulatory requirements applicable to the company's medical device operations. FDA has received and posted the application for public access via Regulations.gov under docket FDA-2025-V-4733-0001.

What changed

B.E. Meyers & Co., Inc. filed a variance application with FDA CDRH requesting permission to deviate from specific medical device regulatory requirements. The application was received and posted to Regulations.gov on April 14, 2025. Variance applications typically allow regulated parties to request alternative compliance approaches when standard requirements are impractical or unnecessary for their specific circumstances.

Affected parties should monitor this docket for FDA review status and any opportunities to comment on the requested variance. While the specific regulatory requirements at issue are not visible in the posted metadata, parties operating similar medical devices or facing comparable regulatory challenges may benefit from tracking this proceeding.

What to do next

  1. Monitor FDA for any requests for additional information
  2. Review the variance application to determine if similar circumstances apply to your operations
  3. Submit comments to FDA if affected by the requested variance

Archived snapshot

Apr 14, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Content

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Attachments 1

Variance Application from B.E. Meyers & Co., Inc.

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA
Published
April 14th, 2025
Instrument
Consultation
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Document ID
FDA-2025-V-4733-0001
Docket
FDA-2025-V-4733-0001

Who this affects

Applies to
Medical device makers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device manufacturing Regulatory compliance Variance requests
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Regulatory Affairs
Topics
Healthcare Radiation Safety

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